Effectiveness of Cerebral Embolic Protection in Transcatheter Aortic Valve Replacement with High Aortic Valve Calcium Burden

Abstract

Abstract Background The use of a cerebral embolic protection device (CEPD) during transcatheter aortic valve replacement (TAVR) has not been shown to be effective in preventing stroke in the PROTECTED-TAVR randomized controlled trial. However, whether CEPD may specifically benefit patients with high aortic valve calcium burden has not been studied. Purpose This study aimed to determine the effectiveness of CEPD in preventing cerebrovascular events during TAVR in patients with high aortic valve calcium scores (AVCS) (>2000 AU in men and >1300 AU in women) detected on baseline computed tomography. Methods We retrospectively analyzed 3505 patients who underwent transfemoral TAVR at a single center between 2016-2020 (Figure 1a). Baseline demographic, clinical, and procedural characteristics were stratified by CEPD use and AVCS (high vs. low). We performed Cox Proportional Hazards regression analysis to examine whether the use of CEPD in patients with high AVCS was associated with a lower rate of cerebrovascular events (stroke or transient ischemic attack) within 30 days (primary outcome) after adjusting for baseline characteristics. Results We stratified our study cohort into four subgroups: low AVCS without CEPD (n=1163), low AVCS with CEPD (n=633), high AVCS without CEPD (n=1081), and high AVCS with CEPD (n=628). Patients for whom CEPD was used in high AVCS group had lower prevalence of peripheral arterial disease compared with no CEPD use. Otherwise, there were no significant differences in the baseline characteristics between patients with and without CEPD in either the low or high AVCS subgroups (Table). In adjusted analysis, CEPD use (HR 1.30 [95% CI, 0.64-2.65)] or high AVCS (HR 1.16 [95% CI, 0.64-2.02)] were not associated with a decreased rate of primary outcome (Figure 1b). Conclusion This study indicates that CEPD use is not associated with lower cerebrovascular events after TAVR, even in patients with a high aortic valve calcium burden. Further research is needed to identify effective stroke prevention strategies for this patient population.Study design and Cox regression analysesBaseline Characteristics and Outcomes